Short and Long-arm Fiberglass Cast Immobilization for Distal Salter Harris I and II Forearm Fractures in Children

April 29, 2026 updated by: University Children's Hospital, Zurich

Unterarm-Combicast Versus Oberarm-Combicast Bei Gelenknahen Distalen (Salter Harris I/II) Radius- Und Vorderarmfrakturen im Kindesalter

The aim of this study is to investigate whether short-arm fiberglass cast (SAC) immobilization provides fracture stabilization comparable to that of long-arm cast (LAC) treatment of displaced and non-displaced distal Salter Harris I/II forearm fractures in paediatric patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients are allocated randomly into the two groups(short-arm cast, long-arm cast). After confirming study participation, patients draw a sealed envelope enclosing a numbered card, which assignes them to one group or other. After choosing the envelope, neither the ED staff nor the parents and their childrenare blinded for the treatment groups. However, the data are going to be analyzed under blinded conditions

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Salter Harris I or II fracture of the distal radius or a forearm fracture
  • informed consent

Exclusion Criteria:

  • open/instable/intraarticular fracture
  • age <4 years or > 16years
  • no informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: short-arm fiberglass cast

salter harris fractures of the distal radius/forearm in children are usually treated with fiberglass long-arm casts. The investigators were able to demonstrate that in distal metaphyseal forearm fracture, treatment with a short-arm cast is not inferior to a long-arm cast.

Patients are going to receive a short-arm cast for fracture treatment.
Device: short-arm fiberglass cast
fracture stabilization of salter harris I/II fractures with a fiberglass short-arm cast
Active Comparator: long-arm fiberglass cast

salter harris fractures of the distal radius/forearm in children are usually treated with a fiberglass long-arm cast.

Patients are going to receive a long-arm cast for fracture treatment.
Device: long-arm fiberglass cast
fracture stabilization of salter harris I/II fractures with a fiberglass long-arm cast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of fracture displacement
Time Frame: in the first four weeks after trauma
difference in fracture angulation values either at pre-treatment or during follow-up between the two groups (short-arm cast; long-arm cast)
in the first four weeks after trauma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital, Zurich

Investigators

  • Study Chair: Michelle Seiler, PD, University Children's Hospital, Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2021

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

December 13, 2021

First Posted (Actual)

December 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UChildrenZurich_salter harris

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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